BioShares Biotechnology Clinical Trials (BBC): $23.32, +$0.43, -19.7% YTD
BioShares Biotechnology Products (BBP): $34.19, +$0.22, +10.9% YTD
U.S. stock index futures were little changed ahead of a testimony by the U.S. Federal Reserve Chair Janet Yellen before a Congressional committee. Markets will also watch for comments by the European Central Bank President Mario Draghi later in the day. Durable goods for August will be in focus on the economic calendar. A rise in Deutsche Bank shares helped push European stocks higher, while Asian stocks closed mostly lower. The dollar strengthened against the yen. Oil prices rose as American Petroleum Institute data showed a surprise draw in U.S. crude stocks. Gold hit a one-week low.
Kitov Pharmaceuticals Holdings announced that its lead drug candidate KIT-302 has successfully completed an additional pharmacokinetic (PK) bioequivalence (BE) study and once more successfully met the U.S. Food and Drug Administration’s (FDA) standards for establishing bioequivalence to the reference drugs. The current study evaluated a lower dosage (2.5 mg) of amlodipine than in Kitov’s previous PK bioequivalence study for the KIT-302 product containing 10 mg of amlodipine, the results of which were announced by Kitov on May 10, 2016.
TxCell SA announced its consolidated financial results for the first half of 2016. The net loss amounted to €7.1 million as of June 30, 2016, compared to €5.7 million at the same date in 2015. As of June 30, 2016, TxCell’s cash and cash equivalents totaled €3.2 million.
TRACON Pharmaceuticals announced a strategic licensing collaboration with Janssen Pharmaceutica N.V. for two novel oncology assets from Janssen’s early development portfolio, with Janssen retaining certain rights to potentially reacquire the programs. Johnson & Johnson Innovation facilitated the collaboration. Johnson & Johnson Innovation – JJDC, Inc. (JJDC) also made a $5 million equity investment in TRACON through the purchase of common stock at a price of $5.95 per share.
Moberg Pharma AB announced that patient enrollment has started in U.S., Canada and Germany in the Phase 3 program investigating MOB-015 for the treatment of onychomycosis. MOB-015 is being evaluated over 52 weeks in two randomized, multicenter, controlled Phase 3 studies. The primary endpoint in both studies is the proportion of patients achieving complete cure of their target nail. In total, approximately 700 patients are expected to be enrolled in the two studies.
Santhera Pharmaceuticals announced that the first patient has been enrolled at the University of Kansas Medical Center, Department of Neurology, Kansas in Santhera`s randomized, double-blind, placebo-controlled phase III (SIDEROS) trial. The trial will assess the efficacy of Raxone in slowing the rate of respiratory function decline in Duchenne muscular dystrophy (DMD) patients receiving concomitant glucocorticoids.
Anavex Life Sciences announced that it has signed a material transfer agreement with Biogen under which Biogen will test Anavex’s lead drug candidate, ANAVEX 2-73 in an oligodendrocyte precursor cell (OPC) differentiation assay. A satisfactory result from the OPC assay study may lead to an in vivo remyelination study using a chemical demyelination model.
Galectin Therapeutics announced topline results from NASH-FX, its Phase IIa clinical trial evaluating the efficacy, safety, and tolerability of GR-MD-02 in 30 nonalcoholic steatohepatitis (NASH) patients with advanced fibrosis. This exploratory, single site, short-treatment (four months of therapy), randomized study did not meet its primary biomarker endpoint as measured by LiverMultiScan, a magnetic resonance imaging test that evaluates inflammation and fibrosis. The trial also did not meet secondary endpoints that measure liver stiffness as a surrogate for fibrosis, with FibroScan (MRE). While all patients had a baseline liver biopsy to establish the diagnosis and fibrosis severity, liver biopsies were not performed at the end of the study following treatment due to safety considerations involved with liver biopsy-related risk in a short duration trial. GR-MD-02 was found to be safe and well tolerated among the patient population with no serious adverse events. Importantly, Galectin simultaneously announced that the principal focus of its research efforts—its larger scale, one-year, multi-site trial in patients with NASH cirrhosis (NASH-CX)—has completed enrollment one month early with 162 total subjects (exceeding the target of 156 patients), allowing for reporting of top-line results in December 2017. In further contrast to the NASH-FX trial, the NASH-CX trial is being conducted with a primary endpoint (hepatic venous pressure gradient (HVPG)) which the FDA may view as an acceptable surrogate for outcomes for registration trials in this patient population.
ARIAD Pharmaceuticals announced that its partner Otsuka Pharmaceutical Co., has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Iclusig (ponatinib) for the treatment of chronic myeloid leukemia (CML) resistant or intolerant to preceding drug treatment and relapsed or treatment resistant Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
Celgene International Sàrl, a wholly owned subsidiary of Celgene, announced that long-term safety findings from ongoing clinical trials of apremilast, the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), were presented at the European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna, Austria.
Pfizer announced the successful completion of its acquisition of Medivation. As of the tender offer expiration, 115,574,041 shares of Medivation common stock were validly tendered, representing approximately 69.1% of the shares outstanding and have been accepted for payment under the terms of the tender offer for $81.50 per share in cash, without interest, subject to any required withholding of taxes. In addition, notices of guaranteed delivery have been delivered for 17,659,861 shares of Medivation common stock, representing approximately 10.6% of the shares outstanding. Following its acceptance of the tendered shares, Pfizer completed its acquisition of Medivation through a second-step merger. Pfizer and its wholly-owned subsidiary accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.
Corbus Pharmaceuticals Holdings announced that Professor Derek Gilroy, Ph.D. presented data on the effects of Resunab in a model of inflammation in healthy volunteers. The presentation was made at the 6th European Workshop on Lipid Mediators at Goethe University in Frankfurt am Main, Germany. Dr. Gilroy, Professor of Experimental Inflammation and Pharmacology at University College of London, presented preliminary data testing effects of Resunab (JBT-101) in a clinical research model of inflammation and its resolution in healthy volunteers. In this established model, inflammation is triggered in healthy individuals by the subcutaneous injection of heat-killed E. coli. Blood flow to the site of inflammation is measured with laser Doppler techniques. Suction blisters are generated over the site of inflammation, and cells and inflammatory mediators are measured in the blister fluid at different times after the injection of E. coli. Subjects receive either oral Resunab or placebo prior to the procedure.
Galapagos reported the successful completion of discussions with the regulatory authorities in the U.S and Europe to initiate the DIVERSITY Phase III study in Crohn’s disease and the SELECTION Phase IIb/III study in ulcerative colitis with filgotinib. Both studies will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in patients with moderately to severely active disease including those with prior antibody therapy failure. First dosing is expected in Q4’16.
GSK and Oncodesign have signed an agreement for Oncodesign to acquire the François Hyafil Research Centre located in Villebon-sur-Yvette (Essonne) from GSK, part of the Paris Saclay innovation cluster, including transfer of the team of highly qualified drug discovery staff located at the site (anticipated to be 57 employees). Under the terms of the agreement, GSK will provide €35 million support over a four year period, and Oncodesign will use this funding to integrate the site and its capabilities into its business and ensure the continued employment of the transferring staff over this period. The agreement is expected to become unconditional and effective by or on 1st December 2016.
Immune Design announced the application of its GLAAS discovery platform in Sanofi‘s Phase I clinical trial evaluating a novel therapeutic candidate for the treatment of peanut allergy. The trial follows an exclusive license agreement with Immune Design to discover, develop and commercialize products to treat a peanut allergy utilizing the company’s GLAAS discovery platform.
Novan announced that the last patient has been randomized in the Company’s two, identically designed Phase III pivotal clinical trials to evaluate the efficacy and safety of topical nitric oxide-releasing product candidate SB204 Gel in the treatment of acne vulgaris, or acne. Novan announced in February that the first patient had been dosed in these trials. Per the study protocol, the last patient randomized will be treated for 12 weeks. The Company is running the two Phase III pivotal trials in parallel and expects to report top-line results in the first quarter of 2017.
Zymeworks and Daiichi Sankyo Company, Limited announced today that they have entered into a cross-licensing and collaboration agreement to develop proprietary cancer immuno-oncology products.
Neurim Pharmaceuticals announced that the first patients have been enrolled in the ReCOGNITION study of its novel drug, piromelatine, for Alzheimer’s disease (AD).
Sanofi Pasteur announced that the Department of Health (DH) has recommended that Zostavax should remain on the UK’s national immunization program to protect seniors from the significant burden of disease associated with shingles. UK adults aged 70 and 78 years old will continue to be offered Zostavax as part of their adult vaccination schedule. Supply of this new tender will start in 2017 for at least two years.
Crescendo Biologics has been granted U.S. patent No. 9,439,405 to its novel transgenic mouse platform (Crescendo Mouse) for generating Humabody drug products.
AbbVie and Eisai Co announced the additional approval for a new indication of HUMIRA (generic name: adalimumab [recombinant]), a fully human anti-TNF-alha monoclonal antibody formulation, in the treatment of non-infectious intermediate, posterior and panuveitis. Through this approval, HUMIRA has become the first biologic treatment available for non-infectious intermediate, posterior and panuveitis regardless of underlying disease.
Incyte announced that the European Society for Medical Oncology (ESMO) has published an abstract (#1110PD) containing updated data from the Phase I portion of the ECHO-202 trial evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. These data will be highlighted in a poster discussion on Monday, 10 October 2016 from 11:00-12:00 CET at the ESMO Annual Congress 2016 in Copenhagen, Denmark. In patients with treatment-naïve advanced melanoma (n=19), updated data show a disease control rate (DCR) of 74 percent and an overall response rate (ORR) of 58 percent. All responses are confirmed and ongoing (median follow-up 42 weeks); median progression-free survival (PFS) has not been reached.
Athersys announced that it has received agreement from the FDA under a SPA for the design and planned analysis of a Phase III clinical trial of Athersys’ novel MultiStem cell therapy product for the treatment of ischemic stroke. The SPA provides agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys’ planned Phase III study are acceptable to support a regulatory submission for approval of the MultiStem product for treating ischemic stroke patients. The results from the Phase III trial entitled, “MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2” (MASTERS-2), together with other available clinical data, would provide the foundation of the regulatory package to be submitted for marketing approval.
Teva Pharmaceutical Industries announced the launch of a generic equivalent of Epzicom (abacavir and lamivudine) tablets, 600 mg/300 mg, in the U.S.. Abacavir and lamivudine tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Boehringer Ingelheim and ViraTherapeutics announced a long term collaboration to jointly develop a next generation oncolytic virus therapy platform and to investigate ViraTherapeutic’s lead candidate VSV-GP (Vesicular Stomatitis Virus (VSV) glycoprotein (GP)) alone and in combination with other therapies. ViraTherapeutics has developed its novel technology with joint support from its lead investors EMBL Ventures and Boehringer Ingelheim Venture Fund (BIVF) and will now be responsible for preclinical and clinical testing of VSV-GP in Phase I trials. Under the terms of the collaboration, Boehringer Ingelheim receives the right to acquire ViraTherapeutics after conclusion of Phase I clinical development.
Dermata Therapeutics announced positive findings from their 28-day Phase I Pharmacokinetic Study in Acne Rosacea patients with their lead compound, DMT210. The results from the Phase I study show that DMT210 has minimal systemic exposure, an acceptable safety profile and appears well tolerated by patients, with most reported local skin reactions as mild.
Karyopharm Therapeutics announced that preclinical and Phase I clinical data describing XPO1 inhibition with selinexor (KPT-330), the Company’s lead, oral Selective Inhibitor of Nuclear Export / SINE(TM) compound, in ovarian cancer models and in patients, were published online in Clinical Cancer Research. The paper, entitled "Inhibition of the Nuclear Export Receptor XPO1 as a Therapeutic Target for Platinum Resistant Ovarian Cancer," discusses scientific results supporting selinexor’s potential as a new therapeutic strategy for platinum resistant ovarian cancer.
Versartis announced that it has commenced an underwritten public offering of shares of its common stock. The company expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock sold in connection with the offering. This offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Cowen, Barclays and Piper Jaffray are acting as joint book-running managers and representatives of the underwriters for the offering. Canaccord Genuity and SunTrust Robinson Humphrey are acting as co-managers.
Array BioPharma announced that it has commenced an underwritten public offering of $100 million of shares of its common stock. Array BioPharma also intends to grant the underwriters a 30-day option to purchase up to an additional $15 million of shares of its common stock offered in the public offering. J.P. Morgan Securities and Cowen are acting as joint book-running managers for the offering.
MyoKardia announced the pricing of an underwritten public offering of 3,800,000 shares of its common stock at a public offering price of $15.00 per share, before underwriting discounts. In addition, the underwriters have a 30-day option to purchase up to an additional 570,000 shares of common stock on the same terms and conditions. Credit Suisse Securities and Cowen are acting as joint lead book-running managers for the offering. BMO Capital Markets Corp. is acting as book-running manager. Wedbush Securities is acting as co-manager.
Bavarian Nordic A/S announced the appointment of Dr. Christopher R. Heery, M.D. to the position of Chief Medical Officer. In this role, Dr. Heery will oversee preclinical and clinical development of the Company’s infectious disease and immuno-oncology portfolio. He will report to Paul Chaplin, CEO, and will be based on the east coast of the United States.
Proteostasis Therapeutics announced the appointment of Naimish Patel, M.D., C.M., and Elizabeth Tullis, M.D., FRCPC, to its clinical advisory board. Dr. Patel is currently a Project Leader in Respiratory, Inflammation and Autoimmunity iMED and Senior Medical Director for AstraZeneca Pharmaceuticals in Sweden. Dr. Tullis serves as Director of the Toronto Adult Cystic Fibrosis Clinic at St. Michael’s Hospital. The recent appointees will join a team of the world’s leading cystic fibrosis experts, including Richard B. Moss, M.D.; Jane C. Davies, M.D., FRCPCH; Michael R. Knowles, M.D.; Felix A. Ratjen, M.D., Ph.D.; Isabelle Sermet-Gaudelus, M.D., Ph.D.; and Pamela L. Zeitlin, M.D., Ph.D.
Assembly Biosciences announced new senior level hires who are primarily focused on advancing the company’s expanding microbiome platform. The new team members include Miguel Barbosa, PhD, as Chief Scientific Officer of the Microbiome Program; George Grandolfi, PhD, as Vice President of Drug Product and Formulation; Steven Cockrill, PhD, as Senior Director of Analytical Development and Quality Control; Christopher Hartnett, PhD, as Senior Director of Process Development; Viktoria Gontcharova, PhD, as Principal Scientist, Bioinformatics and Christopher Howerton, PhD, as Senior Director of Strategy.
Acceleron Pharma announced the Company has appointed Habib Dable as President and Chief Executive Officer to succeed current President and CEO John Knopf. Mr. Dable will assume the CEO role effective December 1, 2016.
SunTrust analyst Peter Lawson increased his price target of Tesaro to $130 from $100, citing increased M&A interest in PARPs.
William Blair analyst Katherine Xu initiated coverage of ContraFect with an “outperform” rating and $7 price target, citing strong chance of success for CF-301 in its upcoming Phase II trial in S. aureus bloodstream infections
Goldman Sachs analyst Terence Flynn decreased his price target of Amgen to $198 from $206, citing Kyprolis is still likely to find use in first-line MM in the US, pending additional details on the forward path the firm will lower the Kyprolis estimates in 2017+.
Jefferies analyst Ben Eaton decreased his price target of Galenica to CHF865 from CHF885, citing the substantial investment behind Veltassa’s launch.
The following analysts increased their price targets of Sarepta, citing updated pricing of Exondys 51: RBC analyst Simos Simeonidis to $108 from $83; JMP analyst Liisa Bayko to $90 from $60.
Roth analyst Michael Higgins increased his price target of Nektar Therapeutics to $23 from $19, citing the collaboration with Bristol-Myers.
Roth analyst Sa’ar Yaniv downgraded Galectin Therapeutics to “sell” from “buy” and decreased his price target to $0.75 from $3, citing the failed NASH Phase II study.
Deutsche Bank analyst Gregg Gilbert decreased his price target of Mallinckrodt to $82 from $84, citing preliminary estimates for the company’s planned divestiture of its Nuclear Imaging business to IBA Molecular.